Early Alert: Anesthesia System Issue from GE HealthCare

The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that GE HealthCare has issued a letter to affected customers recommending updated use instructions for certain Carestation 600 and 700 series…

MediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination

Summary Company Announcement Date: December 10, 2025 FDA Publish Date: December 10, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications. Company Name: MediNatura New Mexico Inc. Brand Name: Brand Name(s) Product Description: Product…

Correction Alert: Olympus Updates Use Instructions for Ligating Device

This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.     Affected…

Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

This communication is an FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Abbott Diabetes Care has issued a letter to distributors, health care providers, and…

Recall Alert: Glycar SA Removes Pericardial Patch

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Glycar SA has issued a letter to affected customers recommending…

Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Device Description: Streamline Bloodline…

Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Life2000 Ventilation System Product Code UDI-DI Number Product Code on Shipping Carton Product…

Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Products Product Names: MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform)  Model…